N/A
N=5,677
Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Utilization and Costs After Discharge From a Hospitalization or Emergency Department Visit on a Regimen of Fluticasone Propionate-Salmeterol Combination Versus Other Maintenance Therapies
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT01332461 ↗Enrolled (actual)
5,677
Serious AEs
—
Results posted
Apr 2011
Primary outcome: Primary: Number of Participants Having a Hospitalization or Emergency Room (ER) Visit Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years — 8.6; 16.3 participants per 100 person-years — p=0.05
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- fluticasone propionate/salmeterol xinafoate combination (Drug); Other maintenance Treatments (OMT) (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Having a Hospitalization or Emergency Room (ER) Visit Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years |
8.6; 16.3 | 0.05 |
| SECONDARY Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years |
2.8; 6.0; 6.6; 12.0; 27.2; 37.4 | <0.05 sig |
| SECONDARY Mean Monthly COPD-related Costs Per Participant |
205; 297; 121; 126; 84; 171 | — |
Summary
This was a retrospective cross-sectional database study using administrative data (study period: 1/1/2003 through 7/31/2008). Managed care enrollees (aged >40 years) having at least one Hospitalization with primary or secondary diagnosis of COPD (ICD code 491.xx, 492.xx and 496.xx) or at least one Emergency Room (ER) visit with primary diagnosis of COPD (index event) during the study period was the target population. All subjects were required to have one year of pre-index period baseline data. COPD events of interest were ER, Hospital and physician visits followed by oral corticosteroids (OCS) or antibiotics (Ab) within 7 days. Other censoring events were treatment switch; loss of enrollment; >60-day gap between medication fills; or end of study period.
This study is a non descriptive hypothesis testing study. Key study hypotheses are listed below.
Specifically the study hypotheses for the primary outcome being tested were:
Ho: There is no difference in risk of COPD-related hospitalization between FSC and OMT Ha: There is a difference in risk of COPD-related hospitalization between FSC and OMT
Hypothesis for the key secondary outcome of COPD-related costs that was tested was:
Ho: There is no difference in COPD-related costs between FSC and OMT Ha: There is a difference in COPD-related costs between FSC and OMT
Eligibility Criteria
Inclusion Criteria
- At least one hospitalization with a primary or secondary diagnosis of COPD or at least one ER visit with a primary diagnosis of COPD
- Initiatiation (prescription) of FSC or non-FSC (i.e. TIO, ICS, LABA, IPR) during peri-index period
- At least 40 years of age
- Continuous eligibility in the pre-index, peri-index, and follow-up periods
Exclusion Criteria
- Presence of exclusionary comorbid conditions during pre-index, peri-index, and follow-up periods: respiratory cancer, cystic fibrosis, fibrosis due to TB, and bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis, sarcoidosis
- Controller medication use during peri-index period
- COPD-related hospitalization, ER visit, or physician visit plus OCS/Abx within 3 days of visit during the peri-index period
Data sourced from ClinicalTrials.gov (NCT01332461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.